BS EN 868-5:2009 pdf free download – Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction一Requirements and test methods.
4.3 Construction and design
4.3.1 Reel material shall be constructed from one layer of poous material and one layer of plastics film, sealed together along parallel sides
Pouches shall be constructed from one layer of porous material and one layer of plastic film by sealing three sides and may include an area to effect closure of the pouch.
4.3.2 The overall width of the seal(s) shall be not less than 6 mm For ribbed seals, the sum of the widths of the nba shall be not less than 6 mm.
4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable the two webs to be separated and peeled apart.
NOTE The side seals can extend beyond the width wise seal to the end of the poudi pmdided that this does not impair peelability
4.3.4 One of the matenals of a pouch shall:
a) be provided with a thumb notch not more than 12 mm deep at either the top or bottom of the pouch or at both ends The bottom of the notch shall be at least 1 mm from the seal; or
b) be lipped such that the length of one web is greater than the length of the other web by not less than 1,0 mm.
43.5 The pouch andlor reel shall be closed according to the manufacturers instructions.
NOTE I For validation requirements for forming, sealing and assembly processes. see EN ISO 11607-2
NOTE 2 The closure and or sealing system may give the possibility to indicate whether or not the seal has been
opened
4.4 Process Indicator
If one or more Class I indicator(s) (process mdicator(s)) are printed on the pouches and tubes, the indicator’s performance shall comply with the requirements of EN ISO 11140-1. Each individual indicator shall be not less than 100 mm’ in area. Indicators shall not be affected by the sealing procedure.
4.5 Performance requirements and test methods
4.5.1 When tested in accordance with the method described in Annex D the strength of the seal joint shall be not less than required for the intended purpose, both before and after being subjected to the sterihzation process.
NOTE 1 The specification for seal strength before arid after exposure to sterilization processes can differ
Minimum value for seal strength in (healthcare facility) shall be 1,5 N per 15 mm for steam sterilization processes and 1,2 N per 15 mm for other sterilization processes.
NOTE 2 For applications outside healthcare facilities. requirements are gin in EN ISO 11607. Report whether the tail was supported or unsupported. see D.6.
4.5.2 The seal shall be continuous and cover the specified width. There shall be no disruption of the surface of the porous material adlacent to the seal lines upon opening, Compliance shall be tested in accordance with Annex E.
4.5.3 For paper according to EN 868-3 and EN 868-6 the direction of the peel marked on the product shall
correspond to that direction which ensures least fibre disturbance. Compliance shall be tested in accordance
with Annex F.
4.6 Marking
4.6.1 Pouches and reels
4.6.1.1
Pouches and reel material shall be clearly marked with the following information unless agreed
otherwise between the supplier and the customer.
a) the words “Do not use if the sterile barrier system is damaged” or other equivalent phrase;
b) lot number;
c) the manufacturers name or trade name;
d) process indicator(s) if applicable;
e) the direction of peel which will ensure the least fibre tear for reels;
f) nominal dimensions and/or identification code.